Director of Regulatory and Clinical Affairs

3 weeks ago


Newport Beach, United States Renata Medical Full time

Renata Medical is seeking an experienced and organized leader to guide and develop global clinical and regulatory activities for pre- and post-approval pediatric cardiovascular medical devices. This role is responsible for developing and leading the strategic plans for regulatory approvals, providing interpretation of regulatory guidelines, leading all regulatory submissions, and managing resources to execute clinical trials. This candidate will work in a cross-functional setting, work on project teams and manage employees to help resolve the complex issues of gaining approval for sale across the globe while obtaining a deep clinical understanding of congenital heart diseases.  This candidate will report directly to the CEO and will play a pivotal role in driving strategic initiatives and working with the leadership team. Renata is a fast-paced startup company that will rely on a motivated, resilient candidate able to work with a small team, embrace new challenges, and execute at a high level in a team setting.


Education and/or Work Experience Requirements

·      Bachelor’s degree

·      6+ years of experience in Regulatory/Clinical experience

·      Deep knowledge of US FDA Class III Medical Device Guidelines

·      Strong knowledge of Class III medical devices and relevant international regulations

·      Excellent written and verbal skills

·      High attention to detail

·      Knowledge of Quality system requirements


Benefits

·      Health insurance

·      Dental insurance

·      Paid time off

·      Vision insurance

·      Stock options


Supplemental Pay

·      Bonus pay



  • Long Beach, United States OBAGI COSMECEUTICAL LLC Full time

    Job DescriptionJob DescriptionWho We Are: Obagi Cosmeceuticals is an industry leading, ~$120M dermo-cosmetic brand that provides transformational skin care products clinically formulated to minimize signs of skin aging, address dark spots, hyperpigmentation, fine lines, and wrinkles. A 35-year legacy backed by science and innovation to protect and enhance...


  • Virginia Beach, VA, United States LifeNet Health Full time

    Vice President, Global Regulatory Affairs Virginia Beach, VA ( Concert Drive ) Regulatory Affairs Job Type: Full-Time Shift: Mon-Fri 5:45AM-2:30PM LifeNet Health is searching for talented individuals who will embrace our mission of saving lives, restoring health, and giving hope. LifeNet Health, headquartered in Virginia Beach, is the largest...

  • Sr Director

    2 weeks ago


    Juno Beach, United States NextEra Energy, Inc Full time

    Requisition ID: 80023 NextEra Energy Resources is the world's largest generator of renewable energy from the wind and sun, and a world leader in battery storage. We provide energy-related products and services that grow our economy, protect the environment, support our communities and help customers meet their energy needs. We are leading the...

  • Sr Director

    17 hours ago


    Juno Beach, United States NextEra Energy, Inc Full time

    Requisition ID: 80023 NextEra Energy Resources is the world's largest generator of renewable energy from the wind and sun, and a world leader in battery storage. We provide energy-related products and services that grow our economy, protect the environment, support our communities and help customers meet their energy needs. We are leading the...


  • Newport Beach, United States Cathworks Full time

    Job DescriptionJob DescriptionSalary: CathWorks, with offices in Israel, USA, Japan, and the Netherlands, is a fast-paced medical device start-up focused on digital health innovations to improve the lives of patients globally. The CathWorks FFRangio® System combines artificial intelligence (AI) and computational science to provide physicians with...


  • Newport Beach, United States Cathworks Full time

    Job DescriptionJob DescriptionSalary: CathWorks, with offices in Israel, USA, Japan, and the Netherlands, is a fast-paced medical device start-up focused on digital health innovations to improve the lives of patients globally. The CathWorks FFRangio® System combines artificial intelligence (AI) and computational science to provide physicians with...


  • Newport Beach, United States Cathworks Full time

    Job DescriptionJob DescriptionSalary: CathWorks, with offices in Israel, USA, Japan, and the Netherlands, is a fast-paced medical device start-up focused on digital health innovations to improve the lives of patients globally. The CathWorks FFRangio® System combines artificial intelligence (AI) and computational science to provide physicians with...


  • Newport Beach, United States Cathworks Full time

    Job DescriptionJob DescriptionSalary: CathWorks, with offices in Israel, USA, Japan, and the Netherlands, is a fast-paced medical device start-up focused on digital health innovations to improve the lives of patients globally. The CathWorks FFRangio® System combines artificial intelligence (AI) and computational science to provide physicians with...


  • Newport News, United States Medical Careers Institute Full time

    Overview This position is based out of our Newport News, VA campus location. Transform your Career at ECPI University Since 1966, ECPI University's employees have been dedicated to helping students achieve their academic and career goals through our unique education model. Our culture is to prioritize our students' success through the support of our dynamic...


  • Newport News, United States ECPI University Full time

    Overview: This position is based out of our Newport News, VA campus location. Transform your Career at ECPI University Since 1966, ECPI Universitys employees have been dedicated to helping students achieve their academic and career goals through our unique education model. Our culture is to prioritize our students success through the support of our dynamic...


  • Long Beach, United States Designory Full time

    **JOB SUMMARY**: The Director of Business Affairs is a Senior role in handling business management duties which include handling usage, license, invoicing and any clearances needed on a video or still image production/project. Understands and plays a key role with managing third party materials and usages for the agency. **Schedule**: Hybrid - In office 3...


  • Long Beach, United States Designory Full time

    **JOB SUMMARY**: The Director of Business Affairs is a Senior role in handling business management duties which include handling usage, license, invoicing and any clearances needed on a video or still image production/project. Understands and plays a key role with managing third party materials and usages for the agency. **Schedule**:Hybrid - In office 3...


  • Laguna Beach, United States Laguna College of Art + Design Full time

    Laguna College of Art + Design, is seeking a full-time experienced Dean of Student Affairs. The College is located in an internationally recognized arts colony in Laguna Beach, California and offers a diversity of majors in Animation, Graphic Design and Digital Media, Fine Art, Game Art, Illustration, and Entertainment Design. **Position Summary**: This is...


  • Myrtle Beach, United States Clinical Management Consultants Full time

    One of South Carolina's state of the art facilities is seeking an Assistant Director Clinical Pharmacy! This 200 bed inpatient hospital is expanding and adding additional members to its team. The Assistant Director Clinical Pharmacy assumes a key lea Director, Clinical, Pharmacy, Assistant, Clinic, Healthcare, Staffing


  • Myrtle Beach, United States Clinical Management Consultants Full time

    One of South Carolina's state of the art facilities is seeking an Assistant Director Clinical Pharmacy! This 200 bed inpatient hospital is expanding and adding additional members to its team. The Assistant Director Clinical Pharmacy assumes a key lea Director, Clinical, Pharmacy, Assistant, Clinic, Healthcare, Staffing


  • Virginia Beach, United States State of Virginia Full time

    Title: Clinical Assistant Professor & Director of Clinical Education - PMHNP Program (Non-Tenure Track) Agency: ACADEMIC AFFAIRS Location: Virginia Beach, VA FLSA: Hiring Range: Full Time or Part Time: Additional Detail Job Description: The School of Nursing at Old Dominion University invites qualified candidates to apply for a full-time, 12-month,...


  • Virginia Beach, United States State of Virginia Full time

    Title: Clinical Assistant Professor & Director of Clinical Education - PMHNP Program (Non-Tenure Track) Agency: ACADEMIC AFFAIRS Location: Virginia Beach, VA FLSA: Hiring Range: Full Time or Part Time: Additional Detail Job Description: The School of Nursing at Old Dominion University invites qualified candidates to apply for a full-time, 12-month,...


  • Deerfield Beach, United States Titan America Full time

    Director, Communications & Public AffairsCOMPANY DESCRIPTION:Titan America LLC, a leading company in the heavy building materials industry in the eastern United States and the North American operating subsidiary of the TITAN Group, is on a growth journey towards becoming the best-in-class vertically integrated cement producer, driving innovation and...


  • Deerfield Beach, United States Titan America Full time

    Director, Communications & Public AffairsCOMPANY DESCRIPTION:Titan America LLC, a leading company in the heavy building materials industry in the eastern United States and the North American operating subsidiary of the TITAN Group, is on a growth journey towards becoming the best-in-class vertically integrated cement producer, driving innovation and...


  • Deerfield Beach, United States Titan America Full time

    Director, Communications & Public AffairsCOMPANY DESCRIPTION:Titan America LLC, a leading company in the heavy building materials industry in the eastern United States and the North American operating subsidiary of the TITAN Group, is on a growth journey towards becoming the best-in-class vertically integrated cement producer, driving innovation and...